The HSE has statutory responsibility for medicine pricing and reimbursement under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. As Minister for Health, I have no role or powers in relation to such matters.
Decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE, including advice from the National Centre for Pharmacoeconomics (NCPE).
The NCPE conducts health technology assessments (HTAs) of medicines for the HSE and makes recommendations on reimbursement to assist the HSE in its decision-making process. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention at the submitted price.
The HSE has a robust assessment and commercial negotiation process for new medicines. This process challenges inappropriate costings from applicant companies and delivers improved value for money on new medicines, allowing more treatments to be provided within a finite budget.
The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments can be ongoing multi-million euro investments. If the HSE were not to challenge pharmaceutical companies pricing fewer medicines could be provided from the resources provided.
I am advised by the HSE that it has received applications for the following indications for osimertinib.
1. The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
In respect of this indication, the HSE received a health technology assessment (cost utility analysis) for this application in May 2018.
A summary copy of that report is available on the NCPE website (www.ncpe.ie) @ http://www.ncpe.ie/wp-content/uploads/2018/05/NCPE-summary-osimertinib-final-draft.pdf.
Following the assessment and after a number of rounds of commercial negotiations and HSE reviews, the HSE notified the applicant in February 2019 that it was minded to not approve osimertinib for the second line treatment of EGFR T790M mutation-positive non-small-cell lung cancers.
The Health (Pricing and Supply of Medical Goods) Act 2013 requires a period of representations after such notifications, before the HSE makes any formal final decision. The HSE reviewed representations received at its May 2019 meeting and is currently considering this.
2. The first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations.
In respect of this indication, a health technology assessment is ongoing. Details on progress through the HTA process are published on the NCPE website @ http://www.ncpe.ie/drugs/osimertinib-tagrisso-for-the-first-line-treatment-of-metastatic-nsclc/.